Enterade in Improving Quality of Life in Patients with Diarrhea due to Carcinoid Syndrome or Neuroendocrine Tumors
- Cohort 1: Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs and telotristat), AND an elevated serum serotonin or plasma serotonin above the upper limit of normal per reference lab
- Cohort 2: Participants who have histopathologically confirmed neuroendocrine tumor and have 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs and telotristat), but are below the cut-point for serotonin elevation
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Karnofsky >= 60%
- Ability to tolerate thin liquids by mouth at the time of enrollment
- Ability to understand and the willingness to sign a written informed consent document
- Subject who are willing to take enterade as instructed will be eligible
- Known allergy to stevia
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection
- Participants with active Clostridium difficile infection will be ineligible for this study
- Participants with a history of inflammatory bowel disease, irritable bowel syndrome, bariatric surgery and/or Celiac disease
- Participants with psychiatric illness/social situations that would limit compliance with study requirements
- Patients who have had enterade within the past 45 days
- Patients who are pregnant, since their pregnancy could affect their gastrointestinal function and make it difficult for them to comply with study requirements
I. To assess how an amino acid based medical food (enterade) (amino acid/electrolyte mixture-based dietary supplement) helps maintain the intestine’s ability to absorb and retain fluids, leading to a reduction in diarrhea due to neuroendocrine tumors and/or carcinoid syndrome.
I. To assess subject reported health-related quality of life in subjects before and after compound administration. (Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea [FACIT-D], Version 4).
II. To characterize the side effect profile and tolerability of enterade as measured by the number of total 8-oz enterade bottles consumed throughout the trial, and average drinks per day.
III. To evaluate changes in serum electrolytes before and after administration of enterade.
IV. To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active enterade period.
V. To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and enterade period.
VI. To compare subjective feeling of bloating and flatulence before and after administration of enterade.
VII. To evaluate changes in patient weight before and after administration of enterade.
I. To assess any change or difference in plasma and stool inflammatory markers to determine intestinal health (IL-1beta, IL-6 and TNF-alpha and plasma endotoxin) before and after enterade.
II. To evaluate fecal lactoferrin in study cohorts.
Patients receive amino acid/electrolyte mixture-based dietary supplement orally (PO) twice daily (BID) on days 1-28 of weeks 5-8 following baseline observation period. Patients are also instructed to document stool output, daily consumption, and symptoms using a diary.
After completion of study, patients are followed up for 4 weeks.
Trial Phase Phase II
Trial Type Supportive care
University of Kentucky / Markey Cancer Center
Lowell Brian Anthony
- Primary ID MCC-18-GI-101-EHS
- Secondary IDs NCI-2018-02490
- Clinicaltrials.gov ID NCT03722511